BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31G X 8MM PEN NEEDLE

    MDR report key: 1902344 · Received November 12, 2010

    Report

    Report Number
    9616656-2010-00022
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    September 7, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED. NO OBVIOUS TRENDS WERE NOTED. DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ANOMALIES NOTED. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED NEEDLE BREAK-OFF IN ABDOMEN. CONSUMER SAW AN MD WHO DID AN X-RAY OF ABDOMEN AND FOUND NO NEEDLE. DOCTOR OPENED HER SKIN TO LOOK FOR NEEDLE BUT NO NEEDLE WAS FOUND. CONSUMER SAW A DIFFERENT MD A WEEK LATER WHO ALSO DID AN X-RAY AND DID SURGICAL PROCEDURE TO REMOVE NEEDLE BUT NO NEEDLE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 31G X 8MM PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA 0008827

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R